To Stay In Race, Glaxo Mimics Automaker

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To develop its Cervarix HPV vaccine as fast as possible, GlaxoSmithKline turned its organization inside out by using the so-called ‘One Roof’ method. Simply put, this involved hand-picking a few dozen employees from R&D, marketing, regulatory and manufacturing, who were assigned to work on nothing but the vaccine for several months.

The urgency was due to the significant headstart Merck had with Gardasil. To close what looked to be a year two-gap, the newly assembled team held impromptu meetings, ran multiple clinical trials simultaneously, convinced management to invest in production capacity, and conducted daily, not monthly, progress checks.

“We knew we had a major asset with our vaccine but if we didn’t want to lose it, we had to accelerate the pace of development dramatically,” Philippe Monteyne, vp of global vaccine developement at GSK Bio, the Belgian-based unit, tells BusinessWeek. The gambit paid off: Instead of filing for regulatory approval in late 2008, Glaxo filed earlier this year in the US, which means Cervarix could be available in the US this year.

The ‘One Roof’ concept, by the way, is credited to French car maker Renault, and may prove to be a salve for the pharmaceutical industry. Drugmakers complain about the time and expense needed to get a new drug to market, but as this demonstrates, they may want to rethink the way their organizations. This isn’t to say another company hasn’t tried the same thing, but if drugmakers don’t consider such concepts, they’ll have no one else to blame for the high cost of failure.

Further reading in BusinessWeek.

[tags]Cervarix, Gardasil, GlaxoSmithKline, HPV, Merck[/tags]

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  1. I recall a similar approach in the past by Abbott.

    The drug was Teflox (temofloxacin) - it was soon withdrawn after launch due to toxicity issues.

    “One roof” can lead to blinkered vision and thinking.

    Maybe ok in car design……. dangerous in medicine development!

  2. Hi Insider,

    Good point. It may not be applicable across the board because one never knows what bigger and lengtheir clincial trials may reveal. I’m sure many scientists would share that concern. And I’m also sure some people would complain about marketers getting too involved in the process too early.

    On the other hand, the notion that employees can focus on one project at a time may prove beneficial. Not everyone can multi-task. such as those of us who assemble eye-popping web sites every day!

    Seriously, I think reorganizing the structure, if not deliberately accelerating timetables, may be worth exploring. Maybe I’m wrong. I’d like to hear more from people who do this sort of thing for a living.

    Cheers
    ed

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